Mental Health DisorderNCT05653700
Arena Labs - Improving Clinician Well Being
A study testing Arena Strive in people with Mental Health Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- Arena Strive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed full time by an Atrium Health affiliated entity
- Age 18+
- Willing and able to give written informed consent for study participation
- Healthcare workers working ≥ 36 hours of clinical duties/week
- Willingness to wear WHOOP and keep it charged for the entire duration of study
- Have a smart phone for pairing with WHOOP and the Arena Strive platform
Who cannot join
- Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea not being treated (with or without continuous positive airway pressure (CPAP) treatment)
- Circadian rhythm sleep-wake disorders
- Narcolepsy
- Recurrent isolated sleep paralysis
- Restless legs syndrome
- Periodic Leg Movement Disorder
Show all 11Show fewer
- Comorbid nocturia or other conditions (benign prostatic hyperplasia) resulting in frequent need to get out of bed to use the bathroom during the night (≥3 times per night average)
- Atrial Fibrillation
- Chronic obstructive pulmonary disease (COPD) other than mild, pulmonary fibrosis or severe chronic lung disease
- Sleep apnea or undergoing treatment for a sleep related illness
- Lack of availability of iPhone or Android device
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
About this study
Official title: Atrium Health - Arena Labs Research Protocol
To determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians.
Read the detailed description
This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform). The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data, and will be worn by all participants in the experimental intervention. Participants will be asked to wear the biometric sensor for 12 weeks but will have optional access to the device for a total of 24 weeks.
- Conditions
- Mental Health Disorder
- Being tested
- Arena Strive, Control Cohort
- Keywords
- professional fulfillment, physiological resilience, high-stress environment
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arena StriveDevice
This second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks).
Control CohortOther
Participants randomized into the control cohort - survey at baseline and end of the study
| Study group | Role | What they receive |
|---|---|---|
| Arena Strive | Experimental | The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). Receives: Device: Arena Strive |
| Control Cohort | Other | Participants randomized into the control cohort - survey at baseline and end of the study Receives: Other: Control Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better
Measured: Week 16
Change in Resting Heart Rate
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
Measured: Week 16
Change in Time Spent in Bed
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Measured: Week 16
Change in Sleep Quality
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Measured: Week 16
Change in Sleep Consistency
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Measured: Week 16
Change in Sleep Debt
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Measured: Week 16
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory
Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout
Measured: Week 16
Change in Self-reported Professional Fulfillment (PFI)
collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment
Measured: Week 16
Change in Self-valuation Scores (Stanford Self-Vaulation)
collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity
Measured: Week 16
Change in Personal Achievement (MBI)
"Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout
Measured: week 16
Change in Depersonalization (MBI)
"Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout
Measured: week 16
Change in Burnout Scores (PFI) - Professional Fulfillment Index
Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion
Measured: week 16
Secondary outcomes (2)
Change in Self-reported Satisfaction of the Arena Strive Platform
collected by means of an in-app survey at key benchmark moments throughout the intervention period - client satisfaction questionnaire 8 (CSQ-8) - Scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Week 12
Recommendation Score of the Arena Strive Platform
Net Promoter Score with the question of likelihood to recommend - Net Promoter Score (NPS) is calculated by (promoters-detractors)/total respondents. The range is -100 to 100. The closer you are to 100 the more likely recommend.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start16 Mar 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform).
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Lobdell, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653700
- Sponsor's protocol ID
- IRB00090882
- Status last verified
- Aug 2023
- First submitted
- 8 Dec 2022
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrium Health - Arena Labs Research Protocol
- ClinicalTrials.gov ID
- NCT05653700
- Acronym / sponsor ID
- IRB00090882
- Conditions
- Mental Health Disorder
- Keywords
- professional fulfillment, physiological resilience, high-stress environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians.
Detailed description
This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform). The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep data, and will be worn by all participants in the experimental intervention. Participants will be asked to wear the biometric sensor for 12 weeks but will have optional access to the device for a total of 24 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective randomized controlled longitudinal crossover design with a per protocol analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive Platform).
| Arm | Type | Receives |
|---|---|---|
| Arena Strive | Experimental | Device: Arena StriveThe experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). |
| Control Cohort | Other | Other: Control CohortParticipants randomized into the control cohort - survey at baseline and end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Employed full time by an Atrium Health affiliated entity
- Age 18+
- Willing and able to give written informed consent for study participation
- Healthcare workers working ≥ 36 hours of clinical duties/week
- Willingness to wear WHOOP and keep it charged for the entire duration of study
Key exclusion criteria (11 listed)
- Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea not being treated (with or without continuous positive airway pressure (CPAP) treatment)
- Circadian rhythm sleep-wake disorders
- Narcolepsy
- Recurrent isolated sleep paralysis
- Restless legs syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arena StriveThis second-generation platform provides frontline clinicians with a comprehensive journey to access the tools, training, and technology used by other high-pressure fields to increase performance and enhance resilience. The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). | Device | Arena Strive |
| Control CohortParticipants randomized into the control cohort - survey at baseline and end of the study | Other | Control Cohort |
Primary outcome
Change in Heart Rate Variability
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better
Change in Resting Heart Rate
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
Change in Time Spent in Bed
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Change in Sleep Quality
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Change in Sleep Consistency
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Change in Sleep Debt
Time frame: Week 16
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory
Time frame: Week 16
Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout
Change in Self-reported Professional Fulfillment (PFI)
Time frame: Week 16
collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment
Change in Self-valuation Scores (Stanford Self-Vaulation)
Time frame: Week 16
collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity
Change in Personal Achievement (MBI)
Time frame: week 16
"Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout
Change in Depersonalization (MBI)
Time frame: week 16
"Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout
Change in Burnout Scores (PFI) - Professional Fulfillment Index
Time frame: week 16
Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion
2 secondary outcomes
Change in Self-reported Satisfaction of the Arena Strive Platform
Time frame: Week 12
Recommendation Score of the Arena Strive Platform
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Lobdell, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arena Strive in people with Mental Health Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (time frame: Week 16). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.